510(k) K860778 ยท GTZ Antisera, All Groups, Streptococcus Spp.
TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 4, 1986 |
| Received | Mar 3, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860778
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.